FEATURED EDITORIAL
ADC success is less about perfect execution and more about early signal detection, tight communication, and decisive governance.
- Real-World Phase-Appropriate Control Lessons For mAb/ADC Manufacturers
- At JP Morgan 2026, Few Showed Up For U.S. Manufacturing
- High Specific Productivity For Leaner Sustainable Bioprocessing
- New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
- Facility Considerations When Retrofitting Legacy Sites For ADCs
- The Metaphoric Rise Of Outsourcing
- In Vivo's Biggest Threat — Comparison To Old Models
GUEST COLUMNISTS
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New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.
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Facility Considerations When Retrofitting Legacy Sites For ADCs
Antibody-drug conjugate manufacturing requires, among other things, unidirectional flow and air locks for people and materials. Facilities often lack these attributes.
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In Vivo's Biggest Threat — Comparison To Old Models
In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.
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Managing Supply Chain Risk In Scale-Up And Multisite Trials
Scaling trials across sites can lock in supply risk early. Learn how biologic variability, long lead times, and multisite complexity threaten trials and how to spot warning signs fast.
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The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.
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Why Use Total Organic Carbon Analysis For Cleaning Validation?
Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.
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Global Clinical Supply — Confronting Persistent Challenges With Strategic Action
From regulatory fragmentation to cold chain risks, discover how strategic action, data visibility, and resilient design keep clinical trials on track.
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December 2025 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
PHARMA OUTSOURCING WHITE PAPERS
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Accelerating The Development And Production Of High-Quality bsAbs
Bispecific antibodies (bsAbs) are revolutionizing medicine by targeting two disease mechanisms simultaneously. Learn about an innovative platform offering excellent pairing and enhanced productivity.
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Scaling With The Client In Mind: A Customer-Centric Approach To Project Scale-Up
In today’s fast-moving biopharma landscape, scaling from clinic to commercial takes more than expertise. See how collaboration can transform scale-up and drive confident progress
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Support Of Scale-Up And Technical Transfer Through Understanding Equipment
See how our expertise in formulation and process development can ensure a seamless scale-up from laboratory to full-scale production of lyophilized injectable products.
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Tablet Manufacturing Technologies For Solid Drug Formulation
Compressed tablets are common oral solid dosages that contain the API and various excipients. Learn about the critical steps in selecting manufacturing methods and excipients to achieve the desired therapeutic effects and stability.
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Application Of Plant And Process Models
Explore innovative process and facility models that optimize efficiency, sustainability, and cost-effectiveness in biopharmaceutical manufacturing.
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Seasonal Vaccine Manufacturing: 3 Areas To Evaluate When Selecting A Partner
Experienced outsourcing partners will have the right facility and technical capabilities, a culture of speed and execution, and shared expectations and commitment to continuous improvement.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- Why Cell Line Screening Is Crucial For Successful CDC Assay Development
- Alerion Microbubble Cell Separation System Used For T Cell Negative Selection
- Accelerating A Complex Molecule From CLD To cGMP In 12 Months
- Set Up And Qualify GMP Laboratories
- Non Animal Origin Squalene For High-Risk Applications
NEWSLETTER ARCHIVE
REPORTING
PRODUCTS & SERVICES
ON-DEMAND WEBINARS
- Selecting A Prefillable Syringe System With Confidence
- Designing Drug Substance Processes For Fill-Finish Compatibility
- DNA-Encoded Library Data: Unlocking Chemomic Insights For Drug Discovery
- Drug Discovery Beyond Rule Of Five: ECCS Class 3 And 4 Strategies
- Viral Clearance Strategies For Monoclonal Antibodies And Proteins